MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

Device Problem Use of Device Problem (1670)

Patient Problems Fainting (1847); Pain (1994); Tachycardia (2095); Dizziness (2194)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the hyperbaric chamber session and oxygen therapy that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2013.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2019.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The root cause for this case is likely due to the cellex operator not following the manufacturer's instructions.The customer acknowledged that they swapped the lines within the kit's treatment bag air detector in order to by pass an alarm #48: treatment bag - air detected alarm during prime.Therakos neither recommends nor approves the swapping of lines within an air detector to resolve an air detected alarm as it eliminates the device's ability to appropriately monitor the kit tubing for air during a treatment.Therakos only recommends that an alarm #48: treatment bag - air detected alarm be resolved using the methods that are written within the cellex operator's manual.According to the cellex operator's manual the customer should have 1.Press mute to silence the alarm, 2.Reinstall the treatment bag line into the air detector, 3.Press reset, 4.Press start, and 5.If the alarm continues, contact therakos for assistance.In addition to swapping the lines within the kit's treatment bag air detector to bypass the alarm #48: treatment bag - air detected alarm during prime, the customer did not return the lines to their original positions prior to placing the patient on the device.As a result, the cellex device was not able to appropriately monitor the line from the treatment bag for air.The customer requested re-training.Trends were reviewed for complaint categories alarm #48: treatment bag - air detected, bubbles observed, dizziness, fainting, pain, and heart rate increased.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: dizziness, fainting, pain, and tachycardia.(b)(4).S.K.8/20/2020.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced dizziness, fainting, thoracic pain, and heart rate increase during an ecp treatment procedure on (b)(6) 2020.The customer stated that an alarm #48: treatment bag - air detected alarm occurred during the priming of the cellex kit and they decided to swap the kit lines within the treatment bag air detector in order to clear the alarm.The customer reported that they then swapped the treatment bag line with the saline line.Therakos neither recommends nor approves the swapping of lines within an air detector to resolve an air detected alarm as it eliminates the device's ability to appropriately monitor the kit tubing for air during a treatment.The customer stated that the alarm was solved by swapping the lines and prime was completed.The customer reported that the swapped lines were not put back to normal when the patient was connected to the device.The customer stated that the patient's ecp treatment went well and the treated cells were reinfused to the patient.The customer reported that when disconnecting the kit's collect line from the patient, they noticed air from the air detector to the patient's access within the kit's return line.The customer stated that they aborted the patient's ecp treatment as soon as they noticed the air in the kit's return line.The customer reported that the patient then complained of thoracic pain, dizziness, and fainted.The customer stated that the patient also experienced tachycardia at 118 beats/minute.The customer reported that the patient's oxygen saturation was at 95%.The customer stated that the treatment physician performed both an arteriole blood gas test and an electrocardiogram.The customer reported that the patient also underwent a hyperbaric chamber session and oxygen therapy (12 liters).The customer stated that the patient was admitted to the hospital overnight for monitoring purposes.The customer reported that the patient was currently in stable condition and underwent a successful ecp treatment using the same instrument the following day, (b)(6) 2020.In addition, the customer stated that this same instrument had also been in use with other patients on the day of the event with no issues.The customer requested re-training.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10435255
• MDR Text Key: 203985470
• Report Number: 2523595-2020-00095
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 80